Safety and Efficacy of GPOEM in the Treatment of Gastroparesis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Functional efficacy
研究概览
简要总结
The purpose of this study is to assess the clinical efficacy and safety in the treatment of gastroparesis.
详细描述
After being informed about the data collected, all the patients affected with gastroparesis undergoing Gastric Per-Oral Endoscopic Myotomy (GPOEM) will be included in the observational protocol.
Data concerning pre-operative symptoms and results of the imaging studies will be recorded together with operative time and operative complications.
Patients will undergo periodical clinical consults and gastric emptying scintigraphy to assess the improvement in the symptoms and gastric motility.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gastroparesis (GCSI > 2 OR Gastric emptying half-time > 180 min OR gastric retention at 120 min > 60% OR good response to botulinum if former criteria not met)
排除标准
- •Age < 18 years
- •Inability to understand protocol
结局指标
主要结局
Functional efficacy
时间窗: 3, 12, 24 months
Change of scintigraphy evaluated gastric emptying time
Complications
时间窗: peri-operative time (48 hours)
Evaluation of the operative adverse events
Clinical efficacy
时间窗: 1, 3, 6, 12, 24 months
Change in symptomatological scores
次要结局
- Correlation of symptoms(3, 12, 24 months)
研究者
Pier Alberto Testoni
Professor
IRCCS San Raffaele